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CompletedNCT01724554ANDROIDUpdated May 22, 2015

Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion

A Phase 1/2 interventional study of Intravitreal Aflibercept Injection in Central Retinal Vein Occlusion and Proliferative Diabetic Retinopathy, sponsored by Ophthalmic Consultants of Boston. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-22.

Sponsored by Ophthalmic Consultants of Boston · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to look at how effective, safe, and well tolerated Intravitreal Aflibercept Injection is in subjects with Central Retinal Vein Occlusion (CRVO) or Proliferative Diabetic Retinopathy (PDR).

Read the detailed description

Protocol available upon request.

02

Conditions studied

  • Central Retinal Vein Occlusion
  • Proliferative Diabetic Retinopathy
03

In context

Retinal Vein Occlusion

291 studies on the registry are indexed under Retinal Vein Occlusion; 29 are open to participants now.

This study's enrollment of 24 is below the median of 49 across 217 interventional studies indexed under Retinal Vein Occlusion.

Browse Retinal Vein Occlusion studies →

Lead sponsor

Ophthalmic Consultants of Boston is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Diagnosis of one or more of the following:

    Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease secondary to CRVO (anterior segment or posterior segment neovascularization).

  2. Be in need of IAI treatment, whether previously treated or treatment-naïve.
  3. Age > 18 years.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy.
  2. Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible.
  3. Presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
  4. Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
  5. Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
  6. History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
  7. Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study.
  8. Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
  9. History of vitrectomy surgery in the study eye.
  10. Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening.
  11. Subjects who received anti-VEGF therapy within 30 days of Screening or received steroid or laser therapy within 90 days of Screening.
  12. Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept
  13. Pregnant or breast-feeding women.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Every Month Treatment

    Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.

    Drug: Intravitreal Aflibercept Injection

  • Experimental
    Every Month, then Every Other Month

    Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed.

    Drug: Intravitreal Aflibercept Injection

Interventions

06

What researchers measure

Primary outcomes

  1. Mean Change in Capillary Non-Perfusion

    To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.

    Time frame: 12 months

07

Study locations

1 site
  • Ophthalmic Consultants of Boston
    Boston, Massachusetts 02114, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2012, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 7, 2012
First posted
Nov 9, 2012
Start
Nov 2012
Primary completionActual
Oct 2014
CompletionActual
Oct 2014
Last update
May 22, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01724554
Lead sponsor
Ophthalmic Consultants of Boston
Collaborators
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Nov 9, 2012
Start date
Nov 2012
Primary completion
Oct 2014
Completion
Oct 2014
Last update
May 22, 2015

Study contacts

Jeffrey S Heier, MD
principal investigator · Ophthalmic Consultants of Boston

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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